Viasys Medsystems · Class II · Cleared Mar 16, 2005
| K-number | K043004 |
| Device name | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 |
| Applicant | Viasys Medsystems |
| Product code | FYA |
| Device class | Class II |
| Decision date | Mar 16, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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